Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)

统计和数据管理中心（SDMC）、艾滋病临床试验组（ACTG）

• 批准号: 10306318
• 负责人: Marlene Ann Cooper
• 金额: $ 1863.13万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-29 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10306318
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adult; Area; Arts; Biometry; Boston; California; Clinical; Clinical Trials; Clinical Trials Cooperative Group; Clinical Trials Network; Collaborations; Communities; Data; Data Collection; Data Management Resources; Databases; Development; Diagnosis; Disease remission; Ensure; Epidemiologist; Epidemiology; Foundations; Funding; Future; HIV; HIV Infections; Hepatitis B Virus; Industry Standard; Infection; Information Dissemination; Infrastructure; International; Intervention; Laboratories; Lead; Leadership; Life; Management Information Systems; Methodology; Methods; Mission; Monitor; National Institute of Allergy and Infectious Disease; Persons; Prevention; Procedures; Public Health Schools; Reporting; Request for Applications; Research; Research Design; Research Personnel; Research Priority; Role; San Francisco; Science; Site; Specimen; Statistical Data Interpretation; System; Technology; Therapeutic Clinical Trial; Training; Tuberculosis; United States; Universities; Viral hepatitis; Work; co-infection; comorbidity; data communication; data harmonization; data management; data sharing; design; epidemiologic data; experience; flexibility; frontier; high standard; improved; innovation; interest; novel; optimal treatments; organizational structure; research and development; trial design; tuberculosis treatment

Project Summary/Abstract This application requests renewal of funding to serve as the Statistical and Data Management Center of the AIDS Clinical Trials Group (ACTG). The ACTG is an international clinical trials network which is proposing to address objectives in NIAID high priority research areas for adults living with HIV. Specifically: to evaluate novel and durable interventions targeting HIV infection; to identify strategies to reduce HIV reservoirs and control HIV replication in the absence of ART (“ART-free remission”); to improve the diagnosis and treatment of tuberculosis, especially in those co-infected with HIV; and to improve the prevention and treatment of co-morbidities and co-infections, including curative strategies hepatitis B virus co-infection. The application's specific aims and long-term objectives are: to support the international research agenda of the ACTG by providing a group of highly-experienced statisticians, epidemiologists, data managers and other professionals who have a deep interest in research in HIV infection and its complications and co-infections; to support the development, conduct and analysis of ACTG studies with expert statistical and data management leadership and high quality clinical and laboratory data management and communications systems which comply with regulatory requirements, meet industry standards and are fully integrated into quality management system workflows; and to advance the mission of the ACTG through innovation in study design and analysis and the development of efficient methods and systems, that facilitate the work of the ACTG and promote harmonization and data sharing with collaborating organizations. The proposed SDMC consists of two components. One is a Statistical and Data Analysis Center at Harvard T.H. Chan School of Public Health which will provide biostatistical leadership, and includes a subcontract to University of California San Francisco to support additional tuberculosis trial design expertise. The second is a Data Management Center at Frontier Science & Technology Research Foundation which will provide expertise and leadership in data management systems, and has primary responsibility for data collection, quality and integrity.

项目总结/摘要 此应用程序要求更新资金，以作为统计和数据管理 艾滋病临床试验组（ACTG）。ACTG是一项国际临床试验 该网络建议解决NIAID成人高优先研究领域的目标 艾滋病毒携带者具体而言：评价针对艾滋病毒感染的新的和持久的干预措施; 确定在没有抗逆转录病毒疗法的情况下减少艾滋病毒储存库和控制艾滋病毒复制的战略 （“无抗逆转录病毒疗法缓解”）;改善结核病的诊断和治疗，特别是在 同时感染艾滋病毒的人;以及改善对同时感染艾滋病毒的人的预防和治疗， 合并感染，包括B型肝炎病毒合并感染的治疗策略。 该申请的具体目标和长期目标是： 通过提供一批经验丰富的统计学家， 流行病学家，数据管理员和其他专业人士谁有浓厚的兴趣在研究中， 艾滋病毒感染及其并发症和合并感染;支持发展、开展和 分析ACTG研究与专家统计和数据管理领导和高 质量临床和实验室数据管理和通信系统， 符合法规要求，符合行业标准，并完全融入质量体系 管理系统工作流程;并通过创新推进ACTG的使命， 研究设计和分析以及开发有效的方法和系统， ACTG的工作并促进协作的协调和数据共享 组织的 拟议的SDMC由两个部分组成。一个是统计和数据分析 中心在哈佛T.H. Chan公共卫生学院将提供生物统计学领导， 并包括一个加州旧金山弗朗西斯科大学，以支持其他 结核病试验设计专业知识。第二个是Frontier的数据管理中心 科学技术研究基金会，将提供数据方面的专业知识和领导力 管理系统，并主要负责数据收集，质量和完整性。